Considering various patterns and progresses of liver diseases, it is very important in the clinical therapy to inhibit the development of fibrosis or cirrhosis or to inhibit the progress of cirrhosis if already developed. So, most researchers studying on treatment of liver diseases have tried to develop preventives or therapeutics for cirrhosis. Nevertheless, satisfactory therapies or therapeutics have not been developed yet.
Continuous liver cell destruction caused by excessive alcohol consumption or toxic substances, or by chronic viral hepatitis leads to decrease in the number of liver cells which constitute liver tissue, and transformation of Ito cells into fibroblasts. Theses processes thereby result in the increase of connective tissue fibers inside liver. Therefore, Inhibition of fibroblastic activation or the fibrotic formation is critical for preventing or treating cirrhosis or in developing a drug. Recently, excessive generation of reactive oxygen species (ROS) and deficiency of their scavenging system such as glutathione system, superoxide dismutase (SOD) or catalase have been reported to elicit and accelerate fibrotic process in the liver. It is known that these conditions can be examined by oxidizing molecules within cells including cell membranes, and then, measuring the level of lipid peroxidation. It is also known that inflammation-related genes such as tumor necrosis factor-alpha (TNF-α), inducible nitric oxide synthase (iNOS) and transforming growth factor-beta (TGF-β) play crucial roles in cell destruction and fibrosis.
Various kinds of single medicines like silymarin extracted from an herbal medicine and combined medicines like Sho-saiko-to (Xiao-Cai-hu-Tang) prepared by decoction of Bupleurum falcatum L., Scutellariae Radix, ginseng, Pinellia ternata, liquorice, ginger and Zizyphus jujuba Miller are known to protect liver cells and to suppress the lipid peroxidation or the expression of inflammation-related genes, and thus, have been widely used in clinical therapy. However, theses drugs show some effectiveness on the improvement of inflammation in liver, but cannot significantly inhibit the progress of liver fibrosis or cirrhosis. Furthermore, liver cirrhosis, an extremely complicated process, is believed to involve many pathological factors, and thus, it is expected to develop a more effective drug by modifying a combined medicine of oriental medicine accumulated from long-time clinical therapies with conducting modern scientific experiments.
Korean Patent Publication No. 2005-100746 discloses an extract for inhibiting liver fibrosis obtained by extracting an herbal mixture of Artemisia capillaris Herba, Atractylodis Rhizoma, Magnoliae officinalis, Aurantii nobilis Pericarpium, Polyporus, Alismatis Rhizoma, Atractylodis Macrocephalae Rhizoma, Poria cocos, Raphani Semen, Zingiber officinale Roscoe, Pinellia ternata, Areca catechu, Sparganii Rhizoma, Zedoariae Rhizoma and Aurantii pericarpium with hot water, and a pharmaceutical composition comprising the same. Korean Patent Publication No. 2005-116007 discloses a pharmaceutical composition for preventing and treating liver diseases essentially containing an extract of Artemisia capillaris Herba, Atractylodis Macrocephalae Rhizoma, Coriolus versicolor, Orostachys japonicus and Polyporus. Korean Patent Publication No. 2006-104405 discloses an herbal extract for preventing and treating liver fibrosis prepared by extracting with a solvent a mixed powder of 17 herbal medicines comprising 3˜5 parts by weight of Euonymus alatus, 3˜5 parts by weight of oyster shell powder, 3˜5 parts by weight of Ampelopsis radix, 3-5 parts by weight of white grub, 1˜3 parts by weight of Artemisia capillaris Herba, 1-3 parts by weight of Alismatis Rhizoma, 1˜3 parts by weight of Bufonis venenum, 1˜3 parts by weight of Rhizomes of Belamcanda chinensis, 0.5˜1.5 parts by weight of Polygonum aviculare Linne, 0.5˜1.5 parts by weight of Raphani Semen, 0.5˜1.5 parts by weight of Curcuma Longa, 0.5˜1.5 parts by weight of Black Cohosh, 0.5˜1.5 parts by weight of Poria cocos, 0.5˜1.5 parts by weight of Eriobotryae folium, 0.5˜1.5 parts by weight of Glycyrrhizae Radix, 0.1˜1 parts by weight of Lepidium apetalum, and 0.1˜1 part by weight of heat-treated alumen. However, these compositions are composed of different components from that of the present invention containing 13 herbal medicines. They have been alleged to have therapeutic effect on liver fibrosis, but still need to be improved in view of effects.